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ICON recognises the importance of strategic analysis and decision-making in drug and device development, and we have a strong track record in advising clients through the development continuum. ICON subject matter experts provide guidance across:

Strategic and Regulatory Planning – Identifying and supporting label claims and strategies for effective product application, regulatory strategy planning and development for all sections of INDs, CTAs, MAAs and NDAs; pharmaceutical and biopharmaceuticals GMP and GLP compliance, due diligence assessment and compliance strategies

Clinical Development – protocol design for adaptive and traditional approaches, full clinical development plans, from First in Human to end of product lifecycle, biosimilar development, scientific oversight of- and operational support for development projects, and compliance